August3, 2017

The Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act builds on the foundation of Klobuchar and Wicker’s bipartisan Patient-Focused Impact Assessment Act, which was signed into law in December as part of the 21st Century CURES Act

WASHINGTON, D.C. – U.S. Senators Amy Klobuchar (D-MN) and Roger Wicker (R-MS) announced that their bipartisan legislation aimed at providing patients the ability to play a larger role in the Food and Drug Administration’s (FDA) benefit-risk framework for drug approvals has passed the Senate. The Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act builds on the foundation of Klobuchar and Wicker’s bipartisan Patient-Focused Impact Assessment Act, which was signed into law as part of the 21st Century CURES Act in December.

“The 21st Century CURES Act was an important milestone for incorporating the patient experience into the drug approval process, but we can’t stop there. This bipartisan legislation will strengthen the consideration of patient experience, especially those with rare diseases, when the Food and Drug Administration is assessing new treatments,” Klobuchar said.

The BENEFIT Act would amend the Food, Drug and Cosmetic Act to ensure that patient experience, patient-focused drug development (PFDD), and related data is considered as part of the FDA’s risk-benefit assessments. This bill would ensure information about patient experience, including data developed by groups like patient advocacy organizations or academic institutions, would be incorporated into the FDA’s approval process.

The legislation is supported by a wide range of patient and rare disease advocacy groups, including the National Organization for Rare Diseases (NORD), the Muscular Dystrophy Association, and Parent Project Muscular Dystrophy (PPMD).

As co-chair of the Rare Disease Congressional Caucus, Klobuchar has worked to make progress on rare disease research and funding, including ensuring that the perspective of patients is considered by FDA reviewers evaluating candidate drugs and other medical products. In 2014, Klobuchar and Wicker’s legislation to help improve the lives of patients with muscular dystrophy was signed into law by the President. The Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education (MD CARE) Amendments of 2014 support medical research and policies to improve treatments and quality of life for muscular dystrophy patients.